BABYGANICS SUNSCREEN  50SPF- octinoxate, octisalate, and zinc oxide lotion 
KAS Direct LLC dba BabyGanics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

babyganics® Sunscreen Lotion 50SPF 2oz

Drug Facts

Active ingredients

Octinoxate 7.5%, Octisalate 5.0%, Zinc oxide 11.7%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months of age: ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long- sleeved shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

water, glyceryl stearate, caprylic/capric triglyceride, propanediol, cyclopentasiloxane, stearyl/octadodecyl citrate crosspolymer, cetyl alcohol, cetearyl alcohol, polysorbate 60, dimethicone crosspolymer, glycerin, tocopheryl acetate, sodium stearoyl glutamate, beeswax, lauryl PEG/PPG-18/18 methicone, triethoxycaprylylsilane, xanthan gum, ethylhexylglycerin, disodium EDTA, potassium sorbate, phenoxyethanol, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil

Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801

PRINCIPAL DISPLAY PANEL - 59 mL Tube Label

50+
SPF

tear
free

water
resistant

babyganics®

mineral-based
sunscreen

broad spectrum SPF 50+
UVA + UVB protection
water resistant
(80 minutes)
non-allergenic

no: PABA, phthalates, parabens,
fragrances or nano-particles

+ NeoNourish Natural
Seed Oil Blend

2 FL OZ (59 mL)

Principal Display Panel - 59 mL Tube Label
BABYGANICS SUNSCREEN   50SPF
octinoxate, octisalate, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1247
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE117 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPANEDIOL (UNII: 5965N8W85T)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MONOSTEARYL CITRATE (UNII: YWW937R1QR)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1247-159 mL in 1 TUBE; Type 0: Not a Combination Product08/01/201312/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/201312/01/2017
Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 7/2020
Document Id: 5e38d317-039d-47a1-bd55-7ae0677aba9e
Set id: 472fe515-5270-47df-9f0f-5fa35cdcd921
Version: 4
Effective Time: 20200714
 
KAS Direct LLC dba BabyGanics